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Commonly reported side effects of lamotrigine include: ataxia, skin rash, headache, insomnia, and nausea. Other side effects include: infection, dyspepsia, abnormal gait, constipation, and drowsiness. See below for a comprehensive list of adverse effects.
Applies to lamotrigine: oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release
Oral route (Tablet; Tablet, Chewable; Tablet, Disintegrating; Tablet, Extended Release)
Cases of life-threatening serious rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis, or rash-related death have been caused by lamotrigine. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include: (1) coadministration with valproate; (2) exceeding recommended initial dose of lamotrigine; or (3) exceeding recommended dose escalation for lamotrigine. Benign rashes are also caused by lamotrigine; however, it is not possible to predict which rashes will prove to be serious or life threatening. Lamotrigine should be discontinued at the first sign of rash, unless the rash is clearly not drug related.
Along with its needed effects, lamotrigine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking lamotrigine:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking lamotrigine:
Symptoms of overdose
Some side effects of lamotrigine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to lamotrigine: oral tablet, oral tablet disintegrating, oral tablet dispersible, oral tablet extended release
The more commonly reported adverse reactions have included dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, and rash.
Postmarketing reports: Progressive immunosuppression, Lupus-like reaction, vasculitis, drug reaction with eosinophilia and systemic symptoms (DRESS), hemophagocytic lymphohistiocytosis (HLH)
In cases of hemophagocytic lymphohistiocytosis (HLH), patients have presented with signs of systemic inflammation (fever, rash, hepatosplenomegaly, and organ system dysfunction) and blood dyscrasias. Symptoms have been reported within 8 to 24 days.
Uncommon (0.1% to 1%): Allergic reaction, chills, malaise
Very common (10% or more): Dizziness (38%), headache (29%), ataxia (22%), somnolence (14%)
Common (1% to 10%): Seizure exacerbation, incoordination, insomnia, tremor, speech disorder, amnesia, hypoesthesia, pain, gait abnormality, vertigo, dyspraxia, confusion, paresthesia
Uncommon (0.1% to 1%): Akathisia, aphasia, central nervous system depression, dysarthria, dyskinesia, hyperkinesia, hypertonia, movement disorder, myoclonus, sudden unexplained death in Epilepsy (SUDEP)
Rare (less than 0.1%): Choreoathetosis, dystonia, extrapyramidal syndrome, faintness, grand mal seizures, hemiplegia, hyperalgesia, hyperesthesia, hypokinesia, hypotonia, neuralgia, muscle spasm, neuralgia, paralysis, peripheral neuritis
Very rare (less than 0.01%): Muscle spasm, paralysis, peripheral neuritis
Postmarketing reports: Exacerbation of Parkinsonian symptoms in patients with pre-existing Parkinson's disease, tics
Sudden unexplained death in epilepsy (SUDEP) was reported in 20 of 4700 patients with epilepsy during premarketing development. While this exceeds the expected rate in healthy populations, it is within the range for patients with epilepsy.
Common (1% to 10%): Depression, anxiety, irritability, disturbance of concentration, emotional lability, abnormal thinking, nervousness
Uncommon (0.1% to 1%): Apathy, euphoria, hallucinations, hostility, depersonalization, memory decrease, mind racing, panic attack, paranoid reaction, personality disorder, psychosis, sleep disorder, stupor, suicidal ideation
Rare (less than 0.1%): Delirium, delusions, dysphoria, manic depression reaction, neurosis
Postmarketing reports: Aggression, nightmares
Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior. Pooled analyses of 199 placebo-controlled clinical trials of 11 different AEDs (monotherapy or adjunctive therapy) showed twice the risk compared with placebo patients; an estimated incidence of 0.43% (n=27,863) in AED-treated patients compared to 0.24% (n=16,029) in placebo. The median treatment duration was 12 weeks. There were 4 suicides in AED-treated patients (placebo=0). The risk of suicidal thoughts or behavior was considered similar among the drugs studied despite their varying mechanisms of action suggesting the risk applies to all AEDs used for any indication. Additionally, the risk did not vary substantially by age.
Very common (10% or more): Diplopia (28%), blurred vision (16%)
Common (1% to 10%): Vision abnormality, nystagmus, photosensitivity, amblyopia
Uncommon (0.1% to 1%): Abnormality of accommodation, conjunctivitis, dry eyes, photophobia
Rare (less than 0.1%): Lacrimation disorder, oscillopsia, ptosis, strabismus, uveitis, visual field defect
Very common (10% or more): Vomiting (20%), nausea (19%), diarrhea (10%)
Common (1% to 10%): Abdominal pain, vomiting, dyspepsia, constipation, anorexia, dry mouth, rectal hemorrhage, peptic ulcer, flatulence
Uncommon (0.1% to 1%): Dysphagia, eructation, gastritis, gingivitis, increased appetite, increased salivation, mouth ulceration
Rare (less than 0.1%): Gastrointestinal hemorrhage, glossitis, gum hemorrhage, gum hyperplasia, hematemesis, hemorrhagic colitis, melena, stomach ulcer, stomatitis, tongue edema
Very rare (less than 0.01%): Pancreatitis, esophagitis
Very common (10% or more): Rhinitis (14%)
Common (1% to 10%): Pharyngitis, increased cough, epistaxis, dyspnea, bronchitis, sinusitis, bronchospasm
Uncommon (0.1% to 1%): Yawn
Rare (less than 0.1%): Hiccup, hyperventilation
Postmarketing reports: Apnea
In adult patients (n=3348), serious rash associated with hospitalization and discontinuation was reported in 0.3% of patients in premarketing epilepsy trials. In bipolar trials, serious rash occurred in 0.08% of patients receiving this drug as initial monotherapy and 0.13% of patients receiving this drug as adjunctive therapy. In worldwide postmarketing experience, rash-related death has been reported, but the numbers are too few to permit a precise estimate of rate.
In a prospectively followed cohort of pediatric patients 2 to 17 years old, the incidence of serious rash was approximately 0.3% to 0.8%. In a prospectively followed cohort of patients 2 to 16 years old (n=1983), 1 rash-related death occurred in a patient with epilepsy taking this drug as adjunctive therapy.
Evidence has show the inclusion of valproate in a multidrug regimen increases the risk of serious, potentially life-threatening rash in both adult and pediatric patients. In pediatric patients who used valproate concomitantly for epilepsy, 1.2% (6 of 482) experienced a serious rash (placebo=0.6%). In adults, 1% of patients of patients receiving this drug in combination with valproate (n=584) experienced a rash (placebo=0.16%).
Very common (10% or more): Rash (14%)
Common (1% to 10%): Contact dermatitis, dry skin, sweating, eczema, pruritus
Uncommon (0.1% to 1%): Acne, alopecia, hirsutism, maculopapular rash, skin discoloration, urticaria, ecchymosis, leukopenia
Rare (less than 0.1%): Angioedema, erythema, exfoliative dermatitis, fungal dermatitis, herpes zoster, leukoderma, multiforme erythema, petechial rash, pustular rash, Stevens-Johnson syndrome, vesiculobullous rash, anemia, eosinophilia, fibrin decrease, fibrinogen decrease, iron deficiency anemia, leukocytosis, lymphocytosis, macrocytic anemia, thrombocytopenia
Common (1% to 10%): Dysmenorrhea, vaginitis, amenorrhea, libido increase, urinary tract infection (both male and female), urinary frequency
Uncommon (0.1% to 1%): Libido decreased, abnormal ejaculation, hematuria, impotence, menorrhagia, polyuria, urinary incontinence
Rare (less than 0.1%): Anorgasmia, breast abscess, breast neoplasm, creatinine increase, cystitis, dysuria, epididymitis, female lactation, nocturia, urinary retention, urinary urgency
Very common (10% or more): Fever (15%), accidental injury (14%)
Common (1% to 10%): Fatigue
Uncommon (0.1% to 1%): Ear pain, taste perversion, tinnitus
Rare (less than 0.1%): Alcohol intolerance, deafness, taste loss, parosmia, taste loss
Common (1% to 10%): Weight decrease, weight gain, peripheral edema, facial edema
Rare (less than 0.1%): Bilirubinemia, general edema, gamma glutamyl transpeptidase increase, hyperglycemia
Common (1% to 10%): Neck pain, arthralgia, myalgia, decreased reflexes, back pain, increased reflexes, asthenia
Uncommon (0.1% to 1%): Arthritis, leg cramps, myasthenia, twitching
Rare (less than 0.1%): Bursitis, muscle atrophy, pathological fracture, tendinous contracture
Postmarketing reports: Rhabdomyolysis (among patients experiencing hypersensitivity reactions)
Common (1% to 10%): Chest pain, migraine
Uncommon (0.1% to 1%): Flushing, hot flashes, hypertension, palpitations, postural hypotension, syncope, tachycardia, vasodilation
Postmarketing reports: Agranulocytosis, hemolytic anemia, lymphadenopathy not associated with hypersensitivity disorder
Common (1% to 10%): Lymphadenopathy
Uncommon (0.1% to 1%): Liver function tests abnormal, aspartate transaminase (AST) increased
Rare (less than 0.1%): Hepatitis, alanine transaminase ALT) increased, acute kidney failure, kidney failure, kidney pain
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